give reply on this.
give reply on this.
For vitamins we can take 10ppm and on the basis of toxicity LD50
what is basic difference between Process validation and process qualification
Anand Kumar Singh
So many of my friends in other forums of askaboutvalidation.com, have answer this Q many times but anyway i give u the exact defination from different guide lines
Qualification is the planning, carrying out and recording of tests on equipment
and a system, which forms part of the validated process, to demonstrate
that it will perform as intended. (WHO TRS 937 eng)
VALIDATION: “Action of proving, in a accordance with the principles of Good Manufacturing Practices, that any procedure, process, equipment, material activity or system actually leads to expected results” (EU GMP Guide)
VALIDATION: “Establishing documents evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes”
PROCESS VALIDATION: Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and characterstics. (FDA guideline 1987)
VALIDATION: “The documented act of demonstrating that any procedure, process equipment, material, activity or system will consistently lead to the expected products.
“PROCESS VALIDATION: Establishing documented evidence with a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. Process validation may take the form of prospective, concurrent or retrospective validation and process qualification or re-validation” (TPD Canada)
APF, SC, Ethiopia
Nice post Shahid Ali hoping this will clear it up for people
Can’t we work out the MACO by using the 0,1% of therapeutic dose for vitamins?
I am currently working on a case where a filling company manufactures a whole range of product from very potent compound to vitamins. Unfortunately due to the criteria of solubility and cleanibility chosen, the vitamin has become one of the worst case product we need to validate. But because it is used in such a low dosage (0,1 mg/ml), our MACO is extremely low, below the LOD.
Does anybody have a suggestion to help out resolve that nutcase?
Thanks a lot